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NCT04369664 · ClinicalTrials.gov registry record · Phase 4
CHOlesterol Lowering and Residual Risk in Type 2 Diabetes
A Phase 4 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 151
- Enrollment target
NCT04369664: Completed Phase 4 study, sponsored by NYU Langone Health.
NCT04369664 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 151 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04369664, a Phase 4 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 151 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate why individuals with type 2 diabetes are at increased risk for heart disease and stroke. This study will investigate risk factors for heart disease and stroke, including platelet (involved in clotting) activity, inflammation, blood vessel wall function, and genetic information (blueprints of your cells), in participants with type 2 diabetes and elevated cholesterol. This study will also include a control group - subjects with elevated cholesterol who do not have diabetes. All participants will be given cholesterol-lowering medicines (PCSK9 inhibitor and statin or ezetimibe) for 1 month with the same risk factors being measured following cholesterol reduction. This study will help understand why individuals with type 2 diabetes are at higher risk for heart disease and stroke before and even after cholesterol reduction.
Primary Outcome
The difference in platelet activity will be assessed by measuring changes in monocyte-platelet aggregates. Monocyte platelet aggregates (MPA) are a robust marker of platelet activity and inflammatory monocytes. The difference in platelet activity before and after cholesterol reduction will be compared using paired t-test or Wilcoxon signed-rank test. The study will also perform a linear mixed model for the multivariate analysis; the primary outcome will be the change in platelet activity (MPA) b
Interventions
- DRUG Statin
- DRUG Ezetimibe 10mg
- DRUG PCSK9 inhibitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2020-08-12 |
| Est. Completion | 2023-10-19 |
| Phase | Phase 4 |
What the finished NCT04369664 record still lists
NCT04369664 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 3 interventions - of which Statin is the first listed.
NCT04369664 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04369664 about?
NCT04369664 is a clinical study titled "CHOlesterol Lowering and Residual Risk in Type 2 Diabetes". The purpose of this study is to investigate why individuals with type 2 diabetes are at increased risk for heart disease and stroke. This study will investigate risk factors for heart disease and stroke, including platelet (involved in clotting) activity, inflammation, blood vessel wall function, an...
What is the current status of trial NCT04369664?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 151 participants. The study started on 2020-08-12. Estimated completion is 2023-10-19.
What interventions are being tested in trial NCT04369664?
The interventions under investigation include: Statin (DRUG), Ezetimibe 10mg (DRUG), PCSK9 inhibitor (DRUG).
Who is sponsoring clinical trial NCT04369664?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04369664's enrollment target sits among peer trials
151 533rd of 2000 higher than 1,468 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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